Pet food supplement

ABSTRACT

This disclosure relates to methods of treating anal gland disease in subjects. In particular, the disclosure provides supplement compositions useful for treatment of anal gland disease. Such compositions comprise a probiotic, a fiber source, and an anti-inflammatory agent.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of Non-Provisional application Ser.No. 13/833,837, filed Mar. 3, 2015, which claims priority to U.S.Provisional Application No. 61/642,895, filed May 4, 2012, thedisclosure of each of which are explicitly incorporated by referenceherein in their entirety.

BACKGROUND OF THE INVENTION Field of the Invention

This disclosure relates to methods of treating anal gland disease inmammals. In particular, the disclosure provides supplement compositionsuseful for treatment of anal gland disease.

Description of Related Art

The anal glands (or anal sacs) are small glands found near the anus inmany mammals, including pets such as dogs and cats. The two glands arelocated on either side of the anus, between the external and internalsphincter muscles. These glands secrete an oily discharge when themammal defecates and this secretion is used for scent marking purposes.As the mammal defecates, the movement of the stool causes pressure overthe glands, which secrete a few drops of liquid.

Many factors can cause the anal glands to not empty properly or tobecome inflamed and irritated, which can lead to various problems forthe mammal. Some factors include poor quality stool (too soft or toosmall to exert pressure on the glands), allergies that may causeinflammation to the glands or the ducts where the liquid is secretedfrom, infection, and poor anatomy. When the glands do not emptyregularly, the pressure builds up within the glands causing discomfort.If this continues an infection may set in and, if left unchecked, anabscess may develop which usually requires surgical treatment. Dogs orcats with severe ongoing anal gland problems may require completesurgical removal of the anal glands by a veterinarian.

The symptoms that a dog or cat with anal gland disease may display are:scooting the rear end on the ground, licking or biting at the rear,straining to defecate, giving away a very foul odor, defecating outsidethe litter box, etc. In severe cases, the sacs may abscess and rupture.Treatment usually involves having the glands manually emptied at aveterinarian's office or groomer. The standard recommendation forlong-term treatment or prevention for animals that have repeatedproblems with their glands is a high fiber diet, which can help to addbulk and firm the stools.

The method by which fiber bulks up the stool is directly correlated tothe ability of fiber to bind water in the large intestine. Feces arecomprised of 75% water and 25% dry weight. The dry weight is comprisedof bacteria and residue from unfermented fiber and excreted compounds.The amount of feces excreted a day varies for any one animal over aperiod of time. Of dietary constituents, only dietary fiber increasesfecal weight. Water is distributed in the colon in three ways: 1) freewater which can be absorbed from the colon, 2) water that isincorporated into bacterial mass, and 3) water that is bound by fiber.Fecal weight is dictated by: the holding of water by the residualdietary fiber after fermentation, the bacterial mass, and, possibly, anadded osmotic effect of products of bacterial fermentation on fecalmass. Insoluble dietary fiber is minimally fermented and binds water.When added to the diet, insoluble fiber increases fecal weight in apredictable linear manner and decreases intestinal transit time. Thegreater the water-holding capacity of the fiber the greater the effecton fecal weight and bulk. For most healthy animals, an increase in wetfecal mass, depending on the particle size of the fiber, is generally onthe order of 3-5 g/g fiber.

SUMMARY OF THE INVENTION

A supplement composition that is to be given to a subject aids intreatment and prevention of anal gland disease. The specific combinationof ingredients improves gastro-intestinal health and producesconsistent, firm, and bulky stools, which helps in natural emptying ofthe glands. The specific combination of ingredients also works inreducing inflammation of the glands that can occur in situations ofchronic anal gland problems, infection, and/or allergies.

Thus, in a broad aspect, the disclosure encompasses supplementcompositions, and methods employing such compositions in the treatmentof anal gland disease in subjects.

One aspect of the disclosure provides a composition comprising (1) aprobiotic, a prebiotic, or both, (2) a fiber source, and (3) ananti-inflammatory agent.

Another aspect of the disclosure provides a composition comprising (1)two or more fiber sources, and (2) at least one additional agentselected from the group selected from a probiotic, a prebiotic, ananti-inflammatory agent, an anti-histamine, an antibiotic, and ananti-diarrhea agent.

Another aspect of the disclosure provides a method of treatment of analgland disease, the method comprising administering to a subject in needof such treatment an effective amount of one or more compositions of thedisclosure.

Another aspect of the disclosure provides a method of preventing analgland disease, the method comprising administering to a subject in needof such treatment an effective amount of one or more compositions of thedisclosure.

Another aspect of the disclosure provides a method of treatment orprevention of anal gland disease, the method comprising administering toa subject in need of such treatment an effective amount of one or morecompositions comprising two or more fiber sources.

DETAILED DESCRIPTION OF THE INVENTION

In one embodiment, the disclosure provides a composition comprising (1)a probiotic, a prebiotic, or both, (2) a fiber source, and (3) ananti-inflammatory agent.

In one embodiment, the disclosure provides a composition comprising (1)a probiotic, (2) a fiber source, and (3) an anti-inflammatory agent. Inanother embodiment, the disclosure provides a composition comprising (1)a prebiotic, (2) a fiber source, and (3) an anti-inflammatory agent. Yetin anther embodiment, the disclosure provides a composition comprising(1) a probiotic and a prebiotic, (2) a fiber source, and (3) ananti-inflammatory agent.

In another embodiment, the disclosure provides a composition comprising(1) two or more fiber sources, and (2) at least one additional agentselected from the group selected from a probiotic, a prebiotic, ananti-inflammatory agent, an anti-histamine, an antibiotic, and ananti-diarrhea agent. In yet another embodiment, at least one additionalagent is the anti-inflammatory agent. In another embodiment, at leastone additional agent is the probiotic. In yet another embodiment, atleast one additional agent is the antibiotic. In one embodiment, theadditional agents are the anti-inflammatory and the probiotic.

The probiotic of the disclosure is a strain selected from the groupconsisting of Bifidobacterium, Lactobacillus, Lactococcus,Saccharomyces, Streptococcus, and a combination thereof. Thus, in oneembodiment, the probiotic is selected from the group consisting of:Bacillus coagulans, Bifidobacterium animalis, Bifidobacterium bifidum,Bifidobacterium breve, Bifidobacterium infantis, Bifidobacterium lactis,Bifidobacterium longum, Lactobacillus acidophilus, Lactobacillus brevis,Lactobacillus casei, Lactobacillus gasseri, Lactobacillus lacti,Lactobacillus paracasei, Lactobacillus johnsonii, Lactobacillusplantarum, Lactobacillus reuteri, Lactobacillus rhamnosus, Enterococcusfaecium, Saccharomyces boulardii, and a combination thereof.

In one embodiment, the composition comprises one probiotic or two ormore of different probiotics.

In another embodiment, the disclosure provides a composition asdescribed above, wherein the probiotic is Bifidobacterium animalis,Bifidobacterium bifidum, Bifidobacterium breve, Bifidobacteriuminfantis, Bifidobacterium lactis, Bifidobacterium longum, Lactobacillusacidophilus, Lactobacillus casei, Lactobacillus paracasei, Lactobacillusjohnsonii, Lactobacillus plantarum, Lactobacillus reuteri, Lactobacillusrhamnosus, and a combination thereof. In yet another embodiment, theprobiotic is Bifidobacterium animalis, Bifidobacterium breve,Bifidobacterium bifidum, Bifidobacterium infantis, Bifidobacteriumlactis, Bifidobacterium longum, and a combination thereof.

In certain embodiments, the disclosure provides a composition asdescribed above, wherein the probiotic is Lactobacillus acidophilus,Lactobacillus brevis, Lactobacillus casei, Lactobacillus gasseri,Lactobacillus lacti, Lactobacillus paracasei, Lactobacillus johnsonii,Lactobacillus plantarum, Lactobacillus reuteri, Lactobacillus rhamnosus,and a combination thereof.

In one example embodiment, the disclosure provides a composition asdescribed above, wherein the probiotic is Lactobacillus acidophilus.

In certain example embodiments, the disclosure provides compositions asdescribed above, wherein the probiotic is in the amount of about 1×10³to about 1×10¹⁰ CFU (colony-forming unit). In other example embodiments,the probiotic is in the amount of about 1×10⁵ to about 1×10⁸ CFU. Inother example embodiments, the probiotic is in the amount of about 1×10⁵to about 1×10⁷ CFU. In other embodiments, the probiotic is in the amountof about 1×10⁶.

The prebiotic of the disclosure is selected from the group consisting ofinulin, lactulose, galacto-oligosaccharide, fructooligosaccharide,mannooligosaccharide, larch arabinogalactan, xylooligosaccharide,polydextrose, tagatose, and a combination thereof. In certain exampleembodiments, the disclosure provides compositions as described above,wherein the prebiotic is in the range of 25 mg to 3000 mg.

The disclosure provides a composition as described above, wherein thefiber source provides bulk and firms up stools. The fiber sourcegenerally includes, but is not limited to, cellulose, pectins, gums,chitin, chitosan, β-glucans, hemicelluloses, inulins, oligofructose,fructooligosaccharides, lignin, polydextrose, psyllium, resistantdextrins, dandelion root, and resistant starch.

Cellulose, a polysaccharide consisting of linear β-(1,4)-linkedglucopyranoside units, is the main structural component of plant cellwalls. Mammals lack digestive enzymes to cleave β-(1,4) linkages andthus cannot absorb glucose from cellulose. Powdered cellulose is apurified, mechanically disintegrated cellulose obtained as a pulp fromwood or cotton and is added to food.

Pectins, which are found in the cell wall and intracellular tissues ofmany fruits and berries, consist of galacturonic acid units withrhamnose interspersed in a linear chain. Pectins frequently have sidechains of neutral sugars, and the galactose units may be esterified witha methyl group, a feature that allows for its viscosity. While fruitsand vegetables contain 5 to 10 percent naturally occurring pectin,pectins are industrially extracted from citrus peels and apple pomace.

Gums consist of a diverse group of polysaccharides typically isolatedfrom seeds. Guar gum is produced by the milling of the endosperm of theguar seed. The major polysaccharide in guar gum is galactomannan.Galactomannans are highly viscous and are therefore used for theirthickening, gelling, and stabilizing properties.

Chitin is an amino-polysaccharide containing β-(1,4) linkages as ispresent in cellulose. Chitosan is the deacetylated product of chitin.Both chitin and chitosan are found in the exoskeletons of arthropods(e.g., crabs and lobsters) and in the cell walls of most fungi. Neitherchitin nor chitosan is digested by mammalian digestive enzymes.

β-Glucans are homopolysaccharides of branched glucose resides. Theseβ-linked D-glucopyranose polymers are constituents of fungi, algae, andhigher plants (e.g., barley and oats).

Hemicelluloses are groups of polysaccharides found in plant cell wallsthat surround cellulose. These polymers can be linear or branched andconsist of glucose, arabinose, mannose, xylose, and galacturonic acid.

Inulin and oligofructose are naturally occurring in a variety of plants.Most of the commercially available inulin and oligofructose is eithersynthesized from sucrose or extracted and purified from chicory roots.Oligofructose is also formed by partial hydrolysis of inulin. Inulin isa polydisperse β-(2,1)-linked fructan with a glucose molecule at the endof each fructose chain. The chain length is usually 2 to 60 units, withan average degree of polymerization. The β-(2,1) linkage is resistant toenzymatic digestion. Synthetic oligofructose contains β-(2,1) fructosechains with and without terminal glucose units. The chain ranges fromtwo to eight monosaccharide residues.

Synthetic fructooligosaccharides have the same chemical and structuralcomposition as oligofructose, except that the degree of polymerizationranges from two to four. The examples of naturally occurring fructansthat are found in plants, include chicory, onions, and Jerusalemartichoke.

Lignin is a highly branched polymer comprised of phenylpropanoid unitsand is found within “woody” plant cell walls, covalently bound tofibrous polysaccharides.

Polydextrose is a polysaccharide that is synthesized by randompolymerization of glucose and sorbitol. Polydextrose serves as a bulkingagent in foods and sometimes as a sugar substitute. Polydextrose is notdigested or absorbed in the small intestine and is partially fermentedin the large intestine, with the remaining excreted in the feces.

Psyllium refers to the husk of psyllium seeds and is a very viscousmucilage in aqueous solution. The psyllium seed, also known as plantagoor flea seed, is small, dark, reddish-brown, odorless, and nearlytasteless. P. ovata, known as blond or Indian plantago seed, is thespecies from which husk is usually derived. P. ramosa is known asSpanish or French psyllium seed.

Indigestible components of starch hydrolysates, as a result of heat andenzymatic treatment, yield indigestible dextrins that are also calledresistant maltodextrins. Unlike gums, which have a high viscosity thatcan lead to problems in food processing and unpleasant organolepticproperties, resistant maltodextrins are easily added to foods and have agood mouth feel. Resistant maltodextrins are produced by heat and/oracid treatment of cornstarch, followed by enzymatic (amylase) treatment.The average molecular weight of resistant maltodextrins is 2,000 daltonsand consists of polymers of glucose containing α-(1-4) and α-(1-6)glucosidic bonds, as well as 1-2 and 1-3 linkages. Resistant starch isnaturally occurring, but can also be produced by the modification ofstarch during the processing of foods. Chemically modified starchincludes starch esters, starch ethers, and cross-bonded starches thathave been produced by the chemical modification of starch.

Thus, in one example embodiment, the composition as described abovecomprises one fiber source or two or more of different fiber sources.

In one example embodiment, the disclosure provides a composition asdescribed above, wherein the fiber source is selected from the groupconsisting of barley, flax seed, digestion resistant maltodextrin, beetpulp, guar gum, inulin, cellulose, larch arabinogalactan,methylcellulose, oat bran, oligofructose, pectin, pumpkin powder,pumpkin seed, psyllium, rice bran, wheat bran, wheat dextrin, and acombination thereof.

In certain example embodiments, the disclosure provides a composition asdescribed above, the fiber source is the fiber source is pectin, pumpkinpowder, pumpkin seed, or a combination thereof.

In certain example embodiments, the disclosure provides compositions asdescribed above, wherein the fiber source is in the amount of about 5%to about 90% weight of the composition (wt %). In other exampleembodiments, the fiber source is in the amount of about 5 to about 70 wt%. In another example embodiment, the fiber source is in the amount ofabout 10 to about 50 wt %. In yet another example embodiment, the fibersource is in the amount of about 15 to about 45 wt %. In other exampleembodiments, the fiber source is in the amount of about 20 to about 40wt %. The fiber source is also in the amount of about 30 wt %.

The disclosure provides a composition as described above, wherein theanti-inflammatory agent treats or prevents inflammation. Theanti-inflammatory generally includes, but is not limited to,non-steroidal anti-inflammatory agents, secondary metabolites (such asflavonoids), herbal agents, eicosanoids, steroids, antioxidants, and thelike.

In one example embodiment, the disclosure provides a composition asdescribed above, wherein the anti-inflammatory agent is selected fromthe group consisting of fish oil, bioflavonoid, bromelain, Vitamin C,Vitamin E, L-glutathione, selenium, reservatol, papain, flax seed oil,curcumin, ginger, alpha lipoic acid, zinc, quercetin, and a combinationthereof. Examples of bioflavonoids include, but are not limited to,quercetin, epicatechin, oligomeric proanthocyanidins, kaempferol,myricetin, fisetin, isorhamnetin, pachypodol, rhamnazin, luteolin,apigenin, tangeritin, hesperetin, naringenin, eriodictyol,homoeriodictyol, taxifolin, and dihydrokaempferol.

In one example embodiment, the composition as described above comprisesone anti-inflammatory agent or two or more of differentanti-inflammatory agents.

In another example embodiment, the disclosure provides a composition asdescribed above, wherein the anti-inflammatory agent is bromelain,quercetin, or a combination thereof.

In yet another example embodiment, the disclosure provides a compositionas described above, wherein the anti-inflammatory agent is in the amountof about 0.1% to about 20% weight of the composition (wt %). In otherexample embodiments, the anti-inflammatory is in the amount of about 0.5to about 15 wt %. In another example embodiment, the anti-inflammatoryagent is in the amount of about 1 to about 10 wt %. In yet anotherexample embodiment, the anti-inflammatory agent is in the amount ofabout 2 to about 10 wt %. In other example embodiments, theanti-inflammatory agent is in the amount of about 3 to about 15 wt %.The anti-inflammatory agent is also in the amount of about 10 wt %. Theanti-inflammatory agent is also in the amount of about 5 wt %.

Any composition as described above may further comprise one or more ofvitamins or minerals. Exemplary vitamins suitable for the composition ofthe disclosure include, but are not limited to, Vitamin A, Vitamin B1,Vitamin B2, Vitamin B3, Vitamin B5, Vitamin B6, Vitamin B7, Vitamin B9,Vitamin B12, Vitamin C, Vitamin D, Vitamin E, and Vitamin K. Exemplaryminerals suitable for the composition of the disclosure include, but arenot limited to, Potassium, Chlorine, Sodium, Calcium, Phosphorous,Magnesium, Zinc, Iron, Manganese, Copper, Iodine, Selenium, andMolybdenum.

In one example embodiment, the composition as described above comprisesVitamin A, Vitamin C, Vitamin D, Vitamin E, Zinc, Iron, and Selenium.

Any composition as described above may further comprise one or more ofnatural immune enhancers. Exemplary natural immune enhancers suitablefor the composition of the disclosure include, but are not limited to,larch tree extract (Arabinogalactan), Echinacea plant extract,Elderberry, lysine, Lactoferrin, and Olea Europa Leaf.

In one example embodiment, the composition as described above compriseslarch tree extract, Echinacea plant extract, and lysine.

Any composition as described above may further comprise one or more ofanti-histamine agents.

Anti-histamine agents include, but are not limited to, azelastine,brompheniramine, buclizine, bromodiphenhydramine, carbinoxamine,cetirizine, cyclizine, chlorpheniramine, chlorodiphenhydramine,clemastine, cyproheptadine, desloratadine, dexbrompheniramine,deschlorpheniramine, dexchlorpheniramine, dimenhydrinate, dimetindene,diphenhydramine, doxylamine, ebastine, embramine, fexofenadine,levocetirizine, loratadine, meclozine, olopatadine, orphenadrine,phenindamine, pheniramine, phenyltoloxamine, promethazine, pyrilamine,quetiapine, rupatadine, tripelennamine, hydroxyzine, and a combinationthereof.

In one example embodiment, the composition as described above comprisesdiphenhydramine, chlorpheniramine, clemastine, hydroxyzine, and acombination thereof.

Any composition as described above may further comprise one or more ofantibiotics.

Examples of suitable antibiotics include, without limitation, amikacin,amoxicillin, amoxicilin-clavulanate, ampicillin, azithromycin,cefazolin, cefovecin, cefoxitin, cefpodoxime, ceftazidime, ceftiofur,cephalexin, chloramphenicol, ciprofloxacin, clindamycin, doxycylcine,enrofloxacin, gentamicin, imipenem, marbofloxacin, meropenem,metronidazole, orbifloxacin, penicillin, potentiated-sulfas,tetracycline, ticarcillin, tylosin, and a combination thereof.

In one example embodiment, the composition as described above comprisesamoxicillin, amoxicilin-clavulanate, cephalexin, enrofloxacin,metronidazole, tylosin, and a combination thereof.

Any composition as described above may further comprise one or more ofanti-diarrhea agents.

Anti-diarrhea agents include, but are not limited to, kaolinite, pectin,loperamide, atropine, diphenoxylate, bismuth subsalicylate, and acombination thereof.

In one example embodiment, the composition as described above compriseskaolinite/pectin, loperamide, diphenoxylate/atropine, and a combinationthereof.

Any composition as described above may further comprise one or more ofingredients for improvement of flavor or palatability. Such ingredientsmay improve color, texture, taste, and smell. For example, theingredients for improvement of flavor are made out of or resemble beef,pork, bacon, lamb, chicken, turkey, duck, liver, venison, fish (e.g.,salmon and tuna), cheese, peanut butter, fruit, vegetable, and herb. Theadditional ingredients are in the amount of about 10% to about 90%weight of the composition (wt %). These agents can also be in the amountof about 20 to about 80 wt %, or about 30 to about 70 wt %, or about 40to about 60 wt %.

In one embodiment, the composition of the disclosure comprises L.Acidophilus, pumpkin seed, quercetin, and bromelain.

In one embodiment, the composition of the disclosure comprises L.Acidophilus, pumpkin seed, quercetin, bromelain, and apple pectin.

In one embodiment, the composition of the disclosure comprises L.Acidophilus, pumpkin seed, quercetin, and bromelain, and kaolinite.

In one embodiment, the composition of the disclosure comprises L.Acidophilus, pumpkin seed, quercetin, and bromelain, apple pectin andkaolinite.

In another aspect, the present disclosure provides methods of treatingor preventing anal gland disease, the method comprising administering toa subject in need of such treatment an effective amount of one or moreof compositions of the disclosure. Any disclosed composition, or acombination of compositions may be used in these methods.

In yet another aspect, the present disclosure provides methods oftreatment or prevention of anal gland disease, the method comprisingadministering to a subject in need of such treatment an effective amountof one or more compositions comprising two or more fiber sources.Suitable fiber sources as described above. In one embodiment of thismethod, the fiber source is pectin, pumpkin, pumpkin seed, or acombination thereof. In another embodiment of this method, the fibersource is pumpkin, pumpkin seed, or a combination thereof.

In one embodiment, the disclosure provides methods of treating analgland disease. In another embodiment, the disclosure provides methods ofpreventing anal gland disease.

The disclosure provides methods as described above, wherein the subjectis a pet. In one embodiment, the subject is a dog or a cat. In anotherembodiment, the subject is a dog. In other embodiment, the subject is acat.

In one example embodiment, the administration is oral.

In certain example embodiments, in the methods as described above, theadministration is in the form of a supplement. In some embodiments, thecomposition is administered as a supplement to the feed. For example,the compositions of the disclosure may be added to a subject's foodduring a regular feeding. In other example embodiments, the compositionis administered without any food concurrently given to the subject. Insome example embodiments, the compositions of the disclosure may beformulated into a pill. In other example embodiments, the compositionsof the disclosure above may be formulated as a powder, tablet, caplet,capsule, or suspension. In other example embodiments, the compositionsof the disclosure may be formulated into a treat or integrated into apet food.

In certain example embodiments, in the methods as described above, theadministration is daily. In other example embodiments, in the methods asdescribed above, the administration is once daily. In other exampleembodiments, in the methods as described above, the administration istwo or three times per day. Daily administration may be over acontinued, long-term period (e.g., from a few days to a few years).

In certain example embodiments, in the methods as described above, theadministration is every other day, twice weekly, or three times weekly.Such administration may be over a continued, long-term period (e.g.,from a few days to a few years).

In certain example embodiments, in the methods as described above, theadministration is episodically, for example on an as needed basis whenthe subject is experiencing anal gland problems for a short-term periodof several months.

In another aspect, the present disclosure provides compositions asdescribed and an appropriate carrier, excipient or diluent. The exactnature of the carrier, excipient or diluent will depend upon the desireduse for the composition, suitable or acceptable for any veterinary use.The composition may optionally include one or more additional compounds.

When used to treat or prevent such diseases, the compositions describedherein may be administered singly, as mixtures of one or morecompositions or in mixture or combination with other agents useful fortreating or preventing such diseases and/or the symptoms associated withsuch diseases. The compounds may also be administered in mixture or incombination with agents useful to treat or prevent other disorders ormaladies, such examples could include steroids, immunosuppressants,antacids, gastro-intestinal protectants, anthelmintics, refluxsuppressants, laxatives, analgesics, as well as additional classes ofdrugs.

Compositions may be manufactured by means of conventional mixing,dissolving, granulating, dragee-making levigating, emulsifying,encapsulating, entrapping or lyophilization processes. The compositionsmay be formulated in conventional manner using one or morephysiologically acceptable carriers, diluents, excipients or auxiliarieswhich facilitate processing of the compounds into preparations which canbe used pharmaceutically.

For oral administration, the compositions may take the form of, forexample, powder, lozenges, tablets or capsules prepared by conventionalmeans with acceptable excipients such as binding agents (e.g.,pregelatinised maize starch, polyvinylpyrrolidone or hydroxypropylmethylcellulose); fillers (e.g., lactose, microcrystalline cellulose orcalcium hydrogen phosphate); lubricants (e.g., magnesium stearate, talcor silica); disintegrants (e.g., potato starch or sodium starchglycolate); or wetting agents (e.g., sodium lauryl sulfate). The tabletsmay be coated by methods well known in the art with, for example,sugars, films, or enteric coatings.

Liquid preparations for oral administration may take the form of, forexample, elixirs, solutions, syrups or suspensions, or they may bepresented as a dry product for constitution with water or other suitablevehicle before use. Such liquid preparations may be prepared byconventional means with acceptable additives such as suspending agents(e.g., sorbitol syrup, cellulose derivatives or hydrogenated ediblefats); emulsifying agents (e.g., lecithin or acacia); non-aqueousvehicles (e.g., almond oil, oily esters, ethyl alcohol, Cremophore™ orfractionated vegetable oils); and preservatives (e.g., methyl orpropyl-p-hydroxybenzoates or sorbic acid). The preparations may alsocontain buffer salts, preservatives, stabilizers, flavoring, coloring,and sweetening agents as appropriate.

Preparations for oral administration may be suitably formulated to givecontrolled release of the ingredients, as is well known.

Oral administration also includes supplements, medicines, nutritionallycomplete diets, veterinary prescription diets, as well as any type ofusual food products, such as, for example, confectionery, pastries,milk-containing products, cereals, biscuits, pet treats, pet chews, petbars, sugar-based and fat-based confectionery products, drinks, liquidcompositions and the like.

The compositions described herein will generally be used in an amounteffective to achieve the intended result, for example in an amounteffective to treat or prevent the anal gland disease. By therapeuticbenefit is meant eradication or amelioration of the anal gland diseaseand/or eradication or amelioration of one or more of the symptomsassociated with the anal gland disease such that the subject shows animprovement in feeling or condition, notwithstanding that the subjectmay still be afflicted with the disease. Therapeutic benefit alsogenerally includes halting or slowing the progression of the anal glanddisease, regardless of whether improvement is realized.

The amount of compositions administered will depend upon a variety offactors, including, for example, the severity of the disease symptoms,the age and weight of the subject, etc. Determination of an effectivedosage of compositions is within the capabilities of those skilled inthe art.

Definitions

The following terms and expressions used herein have the indicatedmeanings.

The term “anti-inflammatory agent”, as used herein, refers to anycompound or mixture of compounds that treats or prevents inflammation.

The term “fiber” or “fiber source” or “dietary fiber”, as used herein,refers to non-digestible carbohydrates and lignin that are intrinsic andintact in plants and have beneficial physiological effects in mammals.Total fiber contains two main components, soluble fiber that is readilyfermented in the colon into gases and metabolically active byproducts(such as short-chain fatty acids), and insoluble fiber that ismetabolically inert, absorbs water as it moves through the digestivesystem, and eases defecation. Unless otherwise specified, fiber includesdietary fiber and/or functional fiber.

The term “probiotic”, as used herein, refers to live microorganisms,which when administered in adequate amounts confer a health benefit onthe host. Probiotics are commonly consumed as part of fermented foodswith specially added active live cultures; such as food supplements.When given to the subject, probiotics may improve the beneficialmicro-flora of the gastro-intestinal tract.

“Treating” or “treatment” as used herein covers the treatment of adisease or disorder described herein, in a subject, preferably a pet,and includes:

-   -   i. inhibiting a disease or disorder, i.e., arresting its        development;    -   ii. relieving a disease or disorder, i.e., causing regression of        the disorder;    -   iii. slowing progression of the disorder; and/or    -   iv. inhibiting, relieving, ameliorating, or slowing progression        of one or more symptoms of the disease or disorder.

“Subject” refers to a warm blooded animal such as a mammal, for examplea pet, or in another example a dog or a cat, which is afflicted with, orhas the potential to be afflicted with the diseases and disordersdescribed herein.

EXAMPLES

The methods of the disclosure are further illustrated by the followingexamples, which are not to be construed as limiting the disclosure inscope or spirit to the specific procedures and compositions described inthem.

Example 1

A supplement composition is prepared by mixing the ingredients as solids(in powdered form) at room temperature. A composition is listed inTable 1. Compositions of different doses can be prepared by modifyingthe loading and the composition of the ingredients and total tabletweight.

TABLE 1 INGREDIENT ACTIVE AMOUNT % Dessicated Beef Liver Powder Active1,675 mg 56.7% Pumpkin Seed Powder Active 890 mg 30.1% Apple PectinCellulose Powder Active 135 mg  4.6% Quercetin Dihydrate Active 100 mg 3.4% Lactobacillus Acidophilus Active 96 mg  3.2% (5 Billion CFU/gram)Bromelain Active 60 mg  2.0% TOTAL 2.956 g  100%

Example 2

A supplement composition is prepared by mixing the ingredients assolids, and this composition is listed in Table 2.

TABLE 2 INGREDIENT ACTIVE AMOUNT % Dessicated Beef Liver Powder Active1,666 mg   50% Quercetin Dihydrate Active 125 mg  3.9% Bromelain Active62.5 mg  1.9% Kaolinite Active 500 mg   15% Apple Pectin CellulosePowder Active 125 mg  3.9% Pumpkin Seed Powder Active 825 mg   25%Lactobacillus Acidophilus Active 10 mg  0.3% (5 billion CFU/gram) TOTAL3.314 g  100%

Example 3

Additional supplements are shown in Tables 3-6.

TABLE 3 INGREDIENT ACTIVE AMOUNT % Dessicated Beef Liver Powder Active1,666 mg   59% Pumpkin Seed Powder Active 825 mg   29% QuercetinDihydrate Active 125 mg  4.6% Apple Pectin Cellulose Powder Active 125mg  4.6% Tylosin Active 62.5 mg  2.3% Lactobacillus Acidophilus Active10 mg  0.5% (5 billion CFU/gram) TOTAL 2.814 g  100%

TABLE 4 INGREDIENT ACTIVE AMOUNT % Dessicated Beef Liver Powder Active1,666 mg   59% Seed Powder Active 825 mg   29% Quercetin DihydrateActive 125 mg  4.6% Apple Pectin Cellulose Powder Active 125 mg  4.6%Bromelain Active 62.5 mg  2.3% Enterococcus Faecium Active 10 mg  0.5%(5 billion CFU/gram) TOTAL 2.814 g  100%

TABLE 5 INGREDIENT ACTIVE AMOUNT % Dessicated Beef Liver Powder Active1,666 mg   50% Quercetin Dihydrate Active 125 mg  3.9% Bromelain Active62.5 mg  1.9% Wheat Bran Active 500 mg   15% Apple Pectin CellulosePowder Active 125 mg  3.9% Pumpkin Seed Powder Active 825 mg   25%Lactobacillus Acidophilus Active 10 mg  0.3% (5 billion CFU/gram) TOTAL3.314 g  100%

TABLE 6 INGREDIENT ACTIVE AMOUNT % Dessicated Beef Liver Powder Active1,666 mg   50% Quercetin Dihydrate Active 125 mg  3.9% Bromelain Active62.5 mg  1.9% Flax Seed Active 500 mg   15% Apple Pectin CellulosePowder Active 125 mg  3.9% Pumpkin Seed Powder Active 825 mg   25%Lactobacillus Acidophilus Active 10 mg  0.3% (5 billion CFU/gram) TOTAL3.314 g  100%

Example 4

The composition of Example 1 was administered as an additive to the petfood on a long-term basis. One ⅛ teaspoon of powder composition is addedto the feed once daily for dogs and cats weighing about 1-15 lbs; one ¼teaspoon of powder composition is added to the feed once daily for dogsand cats weighing about 16-25 lbs; ½ teaspoon of powder composition isadded to the feed once daily for dogs weighing about 26-50 lbs; ¾teaspoon of powder composition is added to the feed once daily for dogsweighing about 51-75 lbs, and 1 teaspoon of powder composition is addedto the feed once daily for dogs 76 pounds or more.

Example 5

Additional supplements of the invention may be prepared are shown inTable 7.

TABLE 7 INGREDIENT ACTIVE AMOUNT % Dessicated Beef Liver Powder Active1675 mg 47.2% Fructo-Oligosaccharide Active 750 mg 21.1% Pumpkin SeedPowder Active 890 mg 25.1% Apple Pectin Cellulose Powder Active 135 mg 3.8% Quercetin Active 100 mg  2.8% TOTAL 3.550 g  100%

It is understood that the examples and embodiments described herein arefor illustrative purposes only. Unless clearly excluded by the context,all embodiments disclosed for one aspect of the invention can becombined with embodiments disclosed for other aspects of the invention,in any suitable combination. It will be apparent to those skilled in theart that various modifications and variations can be made to the presentinvention without departing from the scope of the invention. Thus, it isintended that the present invention cover the modifications andvariations of this invention provided they come within the scope of theappended claims and their equivalents.

What is claimed is:
 1. A method of treatment or prevention of anal glanddisease, the method comprising administering to a subject in need ofsuch treatment an effective amount of one or more compositionscomprising (1) a probiotic, a prebiotic, or both, (2) a fiber source,and (3) an anti-inflammatory agent selected from the group consisting offish oil, bioflavonoid, bromelain, Vitamin C, Vitamin E, L-glutathione,selenium, resveratrol, papain, flax seed oil, curcumin, ginger, alphalipoic acid, zinc, quercetin, and a combination thereof.
 2. The methodaccording to claim 1, wherein the subject is a dog or a cat.
 3. A methodof treatment or prevention of anal gland disease, the method comprisingadministering to a subject in need of such treatment an effective amountof one or more compositions comprising (1) two or more fiber sources,(2) an anti-inflammatory agent selected from the group consisting offish oil, bioflavonoid, bromelain, Vitamin C, Vitamin E, L-glutathione,selenium, resveratrol, papain, flax seed oil, curcumin, ginger, alphalipoic acid, zinc, quercetin, and a combination thereof, and (3)optionally one additional agent selected from the group selected from aprobiotic, a prebiotic, an anti-histamine, an antibiotic, and ananti-diarrhea agent.
 4. The method according to claim 3, wherein thesubject is a dog or a cat.
 5. A method of treatment or prevention ofanal gland disease, the method comprising administering to a subject inneed of such treatment an effective amount of one or more compositionscomprising two or more fiber sources and an anti-inflammatory agentselected from bromelain, quercetin, or a combination thereof.
 6. Themethod according to claim 5, wherein one fiber source is pumpkin orpumpkin seed.
 7. The method according to claim 1, wherein the probioticis a strain selected from the group consisting of Bifidobacterium,Lactobacillus, Lactococcus, Saccharomyces, Streptococcus, and acombination thereof.
 8. The method according to claim 7, wherein theprobiotic is Lactobacillus acidophilus.
 9. The method according to claim1, wherein the fiber source is selected from the group consisting ofbarley, flax seed, digestion resistant maltodextrin, beet pulp, guargum, inulin, cellulose, larch arabinogalactan, methylcellulose, oatbran, oligofructose, pectin, pumpkin powder, pumpkin seed, psyllium,rice bran, wheat bran, wheat dextrin, and a combination thereof.
 10. Themethod according to claim 1, wherein the anti-inflammatory agent isbromelain, quercetin, or a combination thereof.
 11. The method accordingto claim 1, wherein the composition comprises: L. Acidophilus, pumpkinseed, quercetin, and bromelain.
 12. The method according to claim 3,wherein the probiotic is a strain selected from the group consisting ofBifidobacterium, Lactobacillus, Lactococcus, Saccharomyces,Streptococcus, and a combination thereof.
 13. The method according toclaim 12, wherein the probiotic is Lactobacillus acidophilus.
 14. Themethod according to claim 3, wherein the fiber source is selected fromthe group consisting of barley, flax seed, digestion resistantmaltodextrin, beet pulp, guar gum, inulin, cellulose, larcharabinogalactan, methylcellulose, oat bran, oligofructose, pectin,pumpkin powder, pumpkin seed, psyllium, rice bran, wheat bran, wheatdextrin, and a combination thereof.
 15. The method according to claim 3,wherein the anti-inflammatory agent is bromelain, quercetin, or acombination thereof.
 16. The method according to claim 3, wherein thecomposition comprises: L. Acidophilus, pumpkin seed, quercetin, andbromelain.
 17. The method according to claim 1, wherein theanti-inflammatory agent is quercetin, where quercetin is present in theamount of about 3 weight % to about 15 weight %.
 18. The methodaccording to claim 17, wherein the composition further comprising adigestive enzyme.
 19. The method according to claim 18, wherein thedigestive enzyme is bromelain.
 20. The method according to claim 18,wherein the composition further comprising apple pectin.
 21. A method oftreatment or prevention of anal gland disease, the method comprisingadministering to a subject in need of such treatment an effective amountof one or more compositions comprising (1) a probiotic, a prebiotic, orboth, (2) a fiber source, and (3) an anti-inflammatory agent selectedfrom the group consisting of fish oil, bioflavonoid, bromelain, VitaminC, Vitamin E, L-glutathione, selenium, resveratrol, papain, flax seedoil, curcumin, ginger, alpha lipoic acid, zinc, quercetin, and acombination thereof, wherein the administration is oral.
 22. A method oftreatment or prevention of anal gland disease, the method comprisingadministering to a subject in need of such treatment an effective amountof one or more compositions comprising (1) two or more fiber sources,(2) an anti-inflammatory agent selected from the group consisting offish oil, bioflavonoid, bromelain, Vitamin C, Vitamin E, L-glutathione,selenium, resveratrol, papain, flax seed oil, curcumin, ginger, alphalipoic acid, zinc, quercetin, and a combination thereof, and (3)optionally one additional agent selected from the group selected from aprobiotic, a prebiotic, an anti-histamine, an antibiotic, and ananti-diarrhea agent, wherein the administration is oral.
 23. The methodaccording to claim 21, wherein the anti-inflammatory agent is bromelain,Vitamin C, Vitamin E, quercetin, or a combination thereof.
 24. Themethod according to claim 22, wherein the anti-inflammatory agent isbromelain, Vitamin C, Vitamin E, quercetin, or a combination thereof.